Acthar H.P. (corticotropin)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Repository corticotropin is a naturally sourced porcine-derived preparation of corticotropin (ACTH) that has anti-inflammatory and immunomodulatory effects. Unless otherwise specified in this monograph, the term ''corticotropin'' refers to repository corticotropin.
Repository corticotropin is a porcine-derived corticotropin (ACTH; 1-39) in a complex mixture of other pituitary peptides; the drug is supplied in a sterile preparation in 16% gelatin to prolong the activity of ACTH. Endogenous ACTH is an anterior pituitary hormone that stimulates the adrenal cortex to produce and secrete adrenocortical hormones (e.g., cortisol, corticosterone, aldosterone). The release of endogenous ACTH is under the influence of the nervous system via the regulatory hormone released from the hypothalamus and by a negative corticosteroid feedback mechanism.
Elevated plasma cortisol suppresses ACTH release. Corticotropin also appears to bind to melanocortin receptors. For commercial use, corticotropin is available as repository corticotropin injection.
The pharmacokinetics of repository corticotropin have not been adequately characterized. Following IV administration, corticotropin (ACTH) rapidly disappears from the circulation. The plasma half-life in humans is about 15 minutes.
USES: This medication is used to treat a certain type of seizure in babies (infantile spasms). This medication is also used to treat conditions such as multiple sclerosis, arthritis, lupus, eye conditions, skin/kidney/lung diseases, and immune system disorders. It decreases your immune system's response to various diseases to reduce symptoms such as swelling, pain, and allergic-type reactions.
Corticotropin is a hormone.
Generic name: corticotropin
Pronunciation: (KOR-ti-koe-TROE-pin)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Acthar H.P.
Indications
The following indications are listed for Acthar H.P.:
- Acute Exacerbation Of Multiple Sclerosis
- Ankylosing Spondylitis
- Chorioretinitis
- Erythema Multiforme
- Infantile Spasms
- Iridocyclitis
- Iritis
- Juvenile Idiopathic Arthritis
- Keratitis
- Nephrotic Syndrome
- Optic Neuritis
- Psoriatic Arthritis
- Rheumatoid Arthritis
- Serum Sickness
- Stevens-Johnson Syndrome
- Systemic Dermatomyositis
- Systemic Lupus Erythematosus
- Uveitis
Also known as: Acute Exacerbation Of Ms, Acute Iritis, Acute Relapse Of Ms, Acute Relapse Of Multiple Sclerosis, Arthritis Deformans, Arthrosis Deformans, Axial Spondyloarthritis With Radiographic Sacroiliitis, Bekhterev's Arthritis, Bekhterev's Disease, Bekhterev's Spondylitis, Disseminated Lupus Erythematosus, Erythema Polymorphe, Hebra's Disease, Herpes Iris, Infantile Spasm, Inflammation Of The Choroid And The Retina, Inflammation Of The Optic Nerve, Inflammation Of The Retina And The Choroid, Jackknife Seizures, Johnson-Stevens Syndrome, Juvenile Ra, Juvenile Rheumatoid Arthritis, Lupus Erythematosus Syndrome, Marie-Strumpell Disease, Marie-Strumpell Spondylitis, Multiple Sclerosis Exacerbation, Nodose Rheumatism, Psoriasis Arthropica, Psoriatic Arthropathy, Retinochoroiditis, Rheumatic Arthritis, Rheumatic Gout, Rheumatoid Spondylitis, Rhizomelic Spondylitis, Rhizomelic Spondylosis, Salaam Convulsions, Serum Sickness-Like Reaction, Spondylosis Deformans, Strumpell-Marie Disease, West Syndrome.
Dosing
Use the lowest possible dosage of corticotropin to control the condition being treated. When reduction in dosage is necessary, gradually reduce dosage.
Administer repository corticotropin injection by subcutaneous or IM injection. The drug is commercially available in prefilled single-dose SelfJect injectors (Acthar(R) Gel), single-dose prefilled syringes (Purified Cortrophin(R) Gel), or multiple-dose vials (both Acthar(R) Gel and Purified Cortrophin(R) Gel). The prefilled autoinjectors and syringes are for subcutaneous administration only.
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Drug interactions
Formal drug interaction studies have not been conducted with repository corticotropin.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*IV administration.
*Concomitant administration of live or live attenuated vaccines in patients receiving immunosuppressive doses of corticotropin.
*Patients with scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension, primary adrenocortical insufficiency, adrenocortical hyperfunction, or sensitivity to proteins of porcine origin.
*Use of Acthar(R) Gel preparation in infants under 2 years of age who have suspected congenital infections.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
The most common adverse reactions reported in the postmarketing setting with corticotropin (Acthar(R) Gel) include injection site reaction, asthenic conditions (including fatigue, malaise, asthenia, and lethargy), fluid retention (including peripheral swelling), insomnia, headache, and increased blood glucose.
The most common adverse reactions (>=5%) of corticotropin (Acthar(R) Gel) in patients with infantile spasms are increased risk of infections, convulsions, hypertension, irritability, and pyrexia. In the treatment of infantile spasms, other types of seizures/convulsions may occur because some patients with infantile spasms progress to other forms of seizures (e.g., Lennox-Gastaut Syndrome).
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
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Efficacy of repository corticotropin (Acthar(R) Gel) as monotherapy has been established for the treatment of infantile spasms in infants and children less than 2 years of age. Evidence supporting this indication is based on a randomized, single-blinded (video EEG interpreter-blinded) clinical trial and an additional active control supportive trial. Safety in the pediatric population was evaluated by retrospective chart reviews and data from other clinical trials.
Both serious and other adverse reactions that occur in adults can also occur in pediatric patients receiving corticotropin. The frequency and severity of adverse effects may be different in the pediatric population due to the young age of the infant, underlying disorder, duration of therapy, and dosage regimen.
Long-term use of corticotropin can impact growth and physical development in pediatric patients. Pediatric patients receiving prolonged therapy should have their growth and physical development carefully monitored.
Relative adrenocortical insufficiency may occur if corticotropin is withdrawn abruptly. Symptoms of adrenal insufficiency in infants treated with corticotropin for infantile spasms are nonspecific and can be difficult to identify (e.g., anorexia, fatigue, lethargy, weakness, excessive weight loss, hypotension, abdominal pain). Parents and caregivers should be instructed to monitor for these symptoms.
Based on its pharmacological effect of stimulating an endogenous steroid response, corticotropin may cause fetal harm when administered to a pregnant woman. Published literature on systemic corticosteroid use during pregnancy suggests possible adverse fetal/neonatal effects (e.g., intrauterine growth restriction, decreased birth weight, preterm birth), which may be relevant to use of corticotropin. However, the underlying maternal condition may also contribute to these risks. Hypoadrenalism has been reported in infants after high-dose and/or long-term maternal use of corticosteroids during pregnancy. The potential adverse developmental effects of corticotropin have not been adequately assessed in animal reproductive studies.
Carefully observe infants for signs of hypoadrenalism (e.g., poor feeding, irritability, weakness, vomiting) after maternal use of corticotropin during pregnancy and manage accordingly.
It is not known whether corticotropin is distributed into either human or animal milk, or whether the drug has any effects on the breastfed infant or on milk production. Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for corticotropin and any potential adverse effects on the breastfed infant from the drug or underlying maternal condition.
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ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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